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NCT00709202 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
A Phase 2 study, sponsored by Nathan Kline Institute for Psychiatric Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00709202: Completed Phase 2 study, sponsored by Nathan Kline Institute for Psychiatric Research.
NCT00709202 is a Phase 2 study that has completed, run by Nathan Kline Institute for Psychiatric Research. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00709202, a Phase 2 study, has completed, sponsored by Nathan Kline Institute for Psychiatric Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain. Hypothesis to be tested: A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation. B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation. C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation
Primary Outcome
Least Squares estimated change in weight from end of study minus baseline
Interventions
- DRUG Placebo Oral Tablet
- DRUG Betahistine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2008-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00709202 record still lists
NCT00709202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT00709202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00709202 about?
NCT00709202 is a clinical study titled "Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain". The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain. Hypothesis to be tested: A. Patients who have gained a develop...
What is the current status of trial NCT00709202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2008-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00709202?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Betahistine (DRUG).
Who is sponsoring clinical trial NCT00709202?
This trial is sponsored by Nathan Kline Institute for Psychiatric Research, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00709202's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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